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NCT02508324 · ClinicalTrials.gov registry record · Phase 2
IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02508324 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 43 participants.
The verdict
NCT02508324, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the overall safety of adoptive immunotherapy when given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells from a donor to help fight cancer. The donor cells will be either from the umbilical cord blood (UCB) of a newborn baby or they will be cells collected from a relative (haplo-identical cells). The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or haplo-identical stem cells - will be analyzed separately. Preliminary data from other centers has suggested that adoptive immunotherapy with cells from a relative is an effective approach that may improve remission rates and survival in AML and MDS, because they exert anti-cancer effects of their own (so called graft vs leukemia effects) and possibly because they hasten recovery of cell counts from chemotherapy. The Investigators are interested in confirming these data, but also in testing umbilical cord blood cells for the same purpose. Preliminary data indicate that umbilical cord blood cells may have more powerful graft vs leukemia effects and cause fewer side-effects.
Interventions
- BIOLOGICAL haplo-identical cells (donor)
- BIOLOGICAL umbilical cord blood unit (CBU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-09-10 |
| Est. Completion | 2022-06-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02508324
The ClinicalTrials.gov registry entry for NCT02508324 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which haplo-identical cells (donor) is the first listed.
NCT02508324 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02508324 about?
NCT02508324 is a clinical study titled "IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia". The purpose of this study is to determine the overall safety of adoptive immunotherapy when given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells from a donor to help fight cancer. The donor cells will be either from the umbilical cord blood (UCB) of a newborn...
What is the current status of trial NCT02508324?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-09-10. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT02508324?
The interventions under investigation include: haplo-identical cells (donor) (BIOLOGICAL), umbilical cord blood unit (CBU) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02508324?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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